Quality Assurance Manager, GMP Operations

Clinical Dynamix, Inc.; Germantown (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

Clinical Dynamix, Inc. seeks a Quality Assurance Manager, GMP Operations to lead quality assurance for clinical cell-therapy manufacturing.

You will own GMP operations quality on the floor, drive batch disposition, deviations, CAPA, and change control while partnering with Manufacturing, QC, and Analytical Development. You will mentor QA staff, oversee SOPs and document control, and maintain an effective eQMS to ensure cGMP compliance as the company advances toward later-stage clinical

Qualifications

• Bachelor’s degree in a scientific, technical, or regulatory discipline.
• 8+ years in a cGMP environment with progressive QA responsibilities.
• Experience leading QA functions: batch review/release, deviations/CAPA, change control, audits/inspections.
• Strong knowledge of cGMP and FDA regulations for cell and gene therapies.
• Proficiency with eQMS and QC data workflows.
• Experience with risk assessments (FMEA) and supplier quality oversight.

Responsibilities

• Own GMP operations quality for in-house cell-therapy manufacturing, serving as the primary QA contact on the manufacturing floor (Quality on the Floor).
• Lead technical review of Batch Manufacturing Records, logbooks, QC testing records, and validation/calibration documentation.
• Support and coordinate product disposition and release activities with the quality release authority.
• Provide QA oversight for raw material, in-process, and sample release decisions and QC sample submission workflows.
• Own and manage deviations and investigations; lead root-cause analysis and drive CAPA plans to closure.
• Lead and coordinate change controls (assessment, approval, verification) and risk assessments across manufacturing programs.
• Author, revise, and approve SOPs and quality documents; manage document lifecycle and training in the document control system.
• Maintain and improve the eQMS and associated records.
• Establish, track, and analyze QA metrics and trends; present actionable insights to leadership.
• Serve as a primary QA lead for internal and external audits and regulatory inspections; prepare responses and corrective actions.

Skills

Leadership

Quality judgment

Risk assessment

Problem solving

Communication

Time management

Education

Bachelor's degree in a scientific/technical/regulatory field

Tools

LIMS

eQMS

Job description

Quality Assurance Manager, GMP Operations

The Quality Assurance Manager, GMP Operations leads quality assurance for clinical cell-therapy manufacturing, with primary ownership of GMP operations quality — batch disposition support, floor quality, deviation and CAPA management, and change control. This manager-level role owns the day-to-day QA-GMP function, partners closely with Manufacturing, QC, Analytical Development, and Technical Operations, and ensures product quality and cGMP compliance across in-house manufacturing operations. The role combines hands‑on execution with ownership of quality systems and processes, and provides leadership, mentorship, and quality oversight as the organization scales toward later-stage clinical development.

Key Responsibilities

Quality Operations & Batch Disposition

• Own GMP operations quality for in‑house cell‑therapy manufacturing, serving as the primary QA point of contact on the manufacturing floor (“Quality on the Floor”).
• Lead technical review of executed Batch Manufacturing Records, logbooks, QC testing records, and validation/calibration documentation.
• Support and coordinate drug product disposition and release activities in partnership with the quality release authority.
• Provide QA oversight for raw material, in‑process, and sample release decisions and QC sample submission workflows.

Deviations, CAPA & Change Control

• Own and manage complex deviations and investigations; lead root‑cause analysis and drive effective CAPA plans to closure.
• Lead and coordinate change controls (assessment, approval, verification) and risk assessments (impact analyses, FMEA) across manufacturing programs.
• Identify, trend, and elevate quality issues; drive timely, compliant resolution.

Quality Systems & Documentation

• Author, revise, and approve SOPs, work instructions, and quality documents; manage document lifecycle, versioning, and training in the document control system.
• Maintain and improve the electronic quality management system (eQMS) and associated records.
• Establish, track, and analyze QA metrics and trends (deviations, CAPA, audit findings); present actionable insights to leadership.

Audits & Inspection Readiness

• Serve as a primary QA lead for internal and external audits and regulatory inspections of manufacturing operations; prepare responses, corrective actions, and follow‑up.
• Drive and maintain ongoing inspection readiness across GMP operations.

Manufacturing & Technical Operations Partnership

• Partner with Manufacturing and Technical Operations on process improvements, validation studies, tech transfer, and scale‑up, providing quality guidance and oversight.
• Support manufacturing changes and comparability activities from a quality standpoint.
• Interface with suppliers and contract manufacturing/testing partners on quality matters; support supplier qualification and oversight.

Leadership & Team Development

• Lead, mentor, and develop QA staff; set clear expectations, priorities, and escalation paths.
• Foster a proactive quality culture and continuous‑improvement mindset across the organization.
• Represent GMP operations quality in cross‑functional and leadership forums, and help build out the QA function as the company grows.

Qualifications & Technical Skills

Required

• Bachelor’s degree in a scientific, technical, or regulatory discipline.
• Minimum 8 years in a cGMP environment with progressive QA responsibilities, including direct experience in GMP manufacturing operations quality and people or functional leadership.
• Demonstrated ownership across multiple QA functions: batch review/release, deviations/CAPA, change control, document control, and audits/inspections.
• Hands‑on experience leading deviations, CAPAs, audits, and change controls in a GMP manufacturing setting.
• Strong knowledge of cGMP and FDA regulations and expectations for cell and gene therapies (or complex biologics).
• Proficiency with eQMS, document control systems, and QC data workflows (LIMS or similar a plus).
• Experience with risk assessments (e.g., FMEA), validation documentation review, and supplier quality oversight.

Preferred

• Prior experience with cell‑therapy or advanced‑therapy products (CAR‑T, TCR, cell‑based biologics; experience with xenogeneic or other non‑standard cell products a plus).
• Experience supporting in‑house GMP manufacturing and product disposition/release.
• Experience in a small or growing clinical‑stage company, operating hands‑on without large infrastructure.
• Experience supporting tech transfer, scale‑up, and manufacturing changes.

Competencies

• Proven leadership and stakeholder management — able to lead a team, influence cross‑functional partners, and drive timely resolutions.
• Sound, independent quality judgment and risk‑based decision‑making.
• Strong root‑cause / problem‑solving skills and excellent written and verbal communication.
• High attention to detail and commitment to compliance, balanced with practical, phase‑appropriate judgment.
• Able to work independently and manage multiple priorities in a fast‑paced, evolving environment.
• Experience mentoring staff and leading QA projects and improvement initiatives.